Trial document

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Trial Description

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DiaSurg 2 trial - surgical vs. medical treatment of insulin-dependent type 2 diabetes mellitus in patients with a body mass index between 26 and 35 kg/m²

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Trial Acronym

Diasurg 2

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URL of the Trial

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Brief Summary in Lay Language

Approximately six million people in Germany are currently suffering from T2DM (Type 2 Diabetes Mellitus), among whom two million are insulin-dependent. A high proportion of these patients already suffer from T2DM-related diseases, such as micro- and/or macrovascular diseases resulting in neuro-, nephro-, retinopathy, myocardial infarction and stroke.The treatment of these comorbidities renders T2DM one of the most expensive diseases in terms of public health expenditure in Germany. Current guidelines recommend medical therapy for the treatment of T2DM as the gold standard.
Obesity starting from a body mass index (BMI) of 35 kg/m2 or more is considered a risk factor for the development of T2DM. For obese patients, bariatric surgery is recommended when conservative attempts do not result in substantial weight loss. Existing evidence reports that bariatric surgery not only leads to substantial weight loss, but also to T2DM remission in 42-78% of the patients who have undergone laparoscopic Roux-en-Y gastric bypass. In addition, T2DM-related diseases, such as cardiovascular diseases, nephropathy, retinopathy, neuropathy, hyperlipidemia and hypertension, are supposed to be avoided or at least delayed in their progress after metabolic surgery. The beneficial effects of bariatric surgery on T2DM appeared shortly after surgery,and before major weight loss, leading to the hypothesis that weight loss alone is not solely responsible for T2DM remission. In the Swedish Obese Subjects (SOS)-Study 35% of T2DM patients and 19% of patients suffering from preoperative hypertension were still in remission ten years after surgery.In an experimental study, Rubino et al. were able to prove that these effects are not dependent on weight loss alone. These findings led surgeons to perform bariatric procedures on non-severely obese patients (BMI < 35 kg/m2) suffering from T2DM. A recent randomized controlled, single-centre trial in patients with a BMI of 25–35 kg/m² showed T2DM remission in 93% of patients following Roux-en-Y gastric bypass and 47% of patients following laparoscopic gastric sleeve resection. The effect of T2DM remission could therefore also be shown in non-severly obese patients. In the present study 400 patients will be included and randomly assigned to either surgery or medical treatment and will be followed for 8 years.
Thus this randomized controlled multicentre trial assesses whether bariatric surgery can be used as an alternative in the primary care of T2DM, potentially leading to less strokes or cardiovascular death and thus preventing long-term morbidity and mortality well-known in T2DM patients.

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Brief Summary in Scientific Language

This study aims at providing evidence as to whether Roux-en-Y gastric bypass surgery is an efficient method for Type 2 diabetes mellitus glycemic control in non-severely obese patients.

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Organizational Data

  •   DRKS00004550
  •   2012/12/20
  •   [---]*
  •   yes
  •   Approved
  •   S-285/2012, Ethik-Kommission I der Medizinischen Fakultät Heidelberg
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Secondary IDs

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Health Condition or Problem studied

  •   E11 -  Non-insulin-dependent diabetes mellitus
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Interventions/Observational Groups

  •   Laparoscopic Roux-en-Y gastric bypass and standard medical care (S3 guidelines)
  •   Optimal medical care according to the national treatment guidelines for type 2 diabetes mellitus
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  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   No
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Primary Outcome

The primary endpoint is the time from randomization to one of the composite events, including death from cardiovascular causes, non-fatal myocardial infarction, coronary-artery bypass grafting, percutaneous coronary intervention, non-fatal stroke, amputation, and surgery for peripheral atherosclerotic artery disease during the follow-up period of eight years .

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Secondary Outcome

Secondary endpoints include the time to death from any cause and the time to each component of the primary endpoint. In addition, laboratory parameters for T2DM (HbA1c, C-peptide and glucagon stimulated C-peptide, fasting glucose, fasting insulin, oral glucose tolerance test), regular laboratory parameters (i.e. lipid profiles, serum creatinine, creatinin clearance) as well as vitamins and micronutrients (vitamin B6, B12, folate acid and iron status) are assessed. Additional parameters include the amount of medication (insulin dosage, metformin, antihypertensive therapy, etc.), the assessment of nephropathy (urine albumin excretion 24-hours urine sample), retinopathy (according to the EURODIAB six-level grading scale), peripheral neuropathy (assessed by biothesiometry of the big toe in both feet and questionnaire) and quality of life. Data assessment will be after randomization and then 3,6,12 months afterwards and then annually.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • University Medical Center 
  • Medical Center 
  • Medical Center 
  • University Medical Center 
  • Medical Center 
  • University Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • University Medical Center 
  • Medical Center 
  • Medical Center 
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  •   Actual
  •   2013/03/25
  •   400
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   30   Years
  •   70   Years
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Additional Inclusion Criteria

Diagnosis of T2DM with insulin therapy for at least 3 months; Proof of at least one microvascular manifestation of diabetes (e.g., nephropathy, retinopathy, neuropathy);
Residual pancreatic function, which is the premise for autogenic glycaemic control assessed by stimulated fasting C-peptide laboratory tests with a minimum of 1.5 ng/ml; HbA1c at least 7%; ASA at least 3; BMI 26–35 kg/m²; Age 30–70 years;; beta cell autoantibody test for patients who recieved insulin therapy in the past year for diabetes mellitus type II; written informed consent; OK from board-certified endocrinologist

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Exclusion Criteria

Type I diabetes mellitus or latent autoimmune Diabetes in adults (LADA); T2DM on diet and/or oral medication; Heart failure (NYHA III–IV); instable angina pectoris; liver cirrhosis; glucocorticoid or other immunosuppressive therapy; puituitary disease/ M. Addison; renal failure (GFR < 45 ml/min); Pregnancy; malignant disease in the past 5 years (except basalioma); history of major abdominal operation; expected lack of compliance; participation in another interventional study with interference of intervention and outcome; inability to give consent

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Sources of Monetary or Material Support

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    • Manfred Lautenschläger Stiftung
    • Im Breitspiel 9
    • 69126  Heidelberg
    • Germany
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    • Covidien AG
    • Victor Von Bruns Strasse 19
    • 8212   Neuhausen am Rheinfall
    • Switzerland
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    •   ***
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  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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